Society Requests that NCD be Updated on Dual Chamber Pacemakers
Society asks that CMS audits cease until regulations are updated

The Heart Rhythm Society has received reports from electrophysiologists of audits by local Medicare Administrative Contractors (MACs) of dual chamber pacemaker implant procedures. While it is unclear what prompted these actions, review of the National Coverage Determination (NCD) for pacemakers suggests that there is disconnect between evidence-based practice and the Medicare coverage determination.

The Society has sent a comment letter (PDF, 226K) addressing some of the issues raised by local carriers to Donald Berwick, MD, MPP, Centers for Medicare and Medicaid Services (CMS) Administrator. The letter noted that while the NCD was reviewed in 2004 and updated to clarify that pacemaker use should be based on the patient’s medical need and not on the potential risks of pacemakers, the language addressing dual chamber pacing has not been updated in 26 years, despite extensive advances in the pacing field and clinical research. Clinical research findings have been incorporated into clinical practice guidelines, but not into the NCD.

In the letter, the Society recommends that CMS work with heart rhythm care specialists to update the NCD to incorporate more than two decades of scientific data, and to adopt the 2008 ACC/AHA/HRS guideline indications. In the interim, the Heart Rhythm Society urges CMS to reverse denials for implants that meet the current guidelines.

The Society stressed that this approach is permissible if CMS applies the statement made in the 1985 decision that recognizes and allows for clinical judgment.